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OpenTrials
Completed

NCT Number: NCT02943681

A Second Dose of Measles Vaccine (MV) in the Second Year of Life

This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.

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Key information

Age range

18 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.

Exclusion criteria

  • Having severe malformations that impairs their health
  • Having received a second dose of measles vaccine
  • Severely ill (requiring hospitalization) upon clinical examination

Treatment and study plan

Measles vaccine

Biological

Primary outcomes

  1. Mortality

    Time frame: 30 months

    Mortality registered monthly by Health and Demographic Surveillance System fieldworkers. Mortality will be combined with hospital admissions in the analysis to form the outcome severe morbidity. This will be examined overall and by sex

  2. Hospital admissions

    Time frame: 30 months

    Hospital admissions registered daily at the national hospital. Hospital admissions will be combined with mortality in the analysis to form the outcome severe morbidity. This will be examined overall and by sex

Secondary outcomes

  1. Hospital admission by cause

    Time frame: 30 months

    Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex

  2. Consultations

    Time frame: 30 months

    Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2016
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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